MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-07 for NIT-OCCLUD PDA 145096 manufactured by Pfm Medical Mepro Gmbh.
[135542607]
The sample was provided and was used to conduct an investigation. The device history record (dhr) has been reviewed and showed no deviations. The coil, item 145096, was severely defom1ed proximally. Deformations of this kind often occur when a coil needs to be retrieved using a sling. The securing clip on the handle had not been pulled yet. Based on the user statements, the described error feature cannot be reconstructed. The systems are pushed 100% through the enclosed catheter during the test in production. No further similar complaints were reported to mepro in the past. Based on previous experience, insufficient rinsing cannot be ruled out. The complaint is not justified.
Patient Sequence No: 1, Text Type: N, H10
[135542608]
The coil was released inside the patient. Doctor's report: "we tried with a coil and during configuration of the last two loops, is stuck in the catheter refusing to get out or to get back in the catheter we tried a lot until it's released in improper position which force to snare it and send the patient to surgery. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005704822-2018-00002 |
| MDR Report Key | 8316344 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-07 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-01-01 |
| Date Added to Maude | 2019-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TROY TAYLOR |
| Manufacturer Street | 1916 PALOMAR OAKS WAY SUITE 150 |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer G1 | PFM MEDICAL MEPRO GMBH |
| Manufacturer Street | AM S |
| Manufacturer City | NONNWEILER-OTZENHAUSEN, SAARLAND 66620 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 66620 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIT-OCCLUD PDA |
| Generic Name | PDA OCCLUDER |
| Product Code | MAE |
| Date Received | 2019-02-07 |
| Returned To Mfg | 2018-01-15 |
| Model Number | 145096 |
| Catalog Number | 145096 |
| Lot Number | 1018320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PFM MEDICAL MEPRO GMBH |
| Manufacturer Address | AM S?TERBERG 4 NONNWEILER-OTZENHAUSEN, SAARLAND 66620 GM 66620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-07 |